OMNIlife science, Inc. Announces PS Knee FDA Clearance
EAST TAUNTON, Mass., July 5, 2011 /PRNewswire/ – OMNIlife science, Inc. (a subsidiary of Orthopaedic Synergy, Inc.) today announced clearance of its Apex PS Knee by the United States Food and Drug Administration. The Apex Posterior Stabilized (PS) Knee is the latest addition to the Apex Knee product family. The new design was introduced into the European market in the second half of 2010 and has been positively received by surgeons and patients. It is now being introduced into the U.S. market with a full launch expected by the end of 2011. The Apex PS Knee maintains the key design elements of the existing Apex Cruciate Retaining (CR) Knee but offers the post and cam system preferred by surgeons who utilize a posterior stabilized knee replacement. The innovative design allows the Apex PS Knee to have up to an additional 30 degrees of uninterrupted patella track compared to competitive posterior stabilized knee designs that require a larger bone resection. The extra patella track potentially reduces the chance of experiencing a problem that has been associated with knee replacements known as patella “clunk”. A single step reaming process allows a seamless intraoperative transition from a CR Knee to a PS Knee based on surgeon preference. By taking advantage of the intercondylar fossa for the location of the Apex PS Knees’ “box” cut, there is as much as a 90% reduction in the bone removed compared to some competitive PS knee designs.
“We believe that the design of the Apex PS Knee will set a new standard in the Orthopaedic industry that will benefit both patients and surgeons,” said George Cipolletti, Chief Executive Officer of OMNIlife science, Inc. and Orthopaedic Synergy, Inc.
“I really enjoy using the instruments for the Apex PS knee; it’s certainly the easiest and most repeatable box cut that I have ever made,” said Anthony F. Infante, Jr., D.O. “In the past, I’ve typically used an ultra congruent insert for posterior stabilization because of the amount of bone that was removed in a typical PS Knee. With the OMNI system, the amount of additional bone that is removed is so insignificant I have no problem using this PS Knee in all of my patients.”
About OMNIlife science, Inc.
OMNIlife science, Inc. was founded in 1999 as an organization committed to the design, manufacture and distribution of high quality, innovative orthopaedic devices. Corporate headquarters are located in East Taunton, Massachusetts. OMNI’s products are prescribed by orthopaedic surgeons for their patients who require total joint replacement. By continuing to challenge the design and functionality of our products based on persistent advances in reconstructive surgical techniques, anatomic and biomechanical data, as well as input from surgeons, the Company is emerging as a leader in modular hip stem technology and total knee replacement systems. Additional information can be found at www.omnils.com.
About Orthopaedic Synergy, Inc.
Orthopaedic Synergy, Inc. functions as a holding company for OMNIlife science, Inc., Enztec Limited and PRAXIM, SA. Together these companies represent a global reconstructive orthopaedic concern that is committed to the design, manufacture and distribution of high quality orthopaedic devices. Company objectives include continued growth through strategic acquisition of organizations with complementary technology. The goal is to acquire firms that enhance the development of line extensions to our company’s current product offerings as well as innovative new products that provide improved clinical options for our customers. Additional information can be found at www.orthopedicsynergy.com.
SOURCE OMNIlife science, Inc.